Primary Device ID | 03701089524018 |
NIH Device Record Key | 0b8e9874-c387-49d1-942f-16521280639f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Crescendo Femoral Component Cemented - PS Size 3R |
Version Model Number | 1-01-07-1063 |
Company DUNS | 634855407 |
Company Name | AMPLITUDE SAS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +0033475418741 |
regulatoryaffairs@amplitude-ortho.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03701089524018 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-12-11 |
Device Publish Date | 2018-10-16 |
03701089501071 - VENTO Fixation Screw | 2024-02-19 |
03701089514309 - VENTO Fixation Screw | 2024-02-19 |
03701089514316 - VENTO Fixation Screw | 2024-02-19 |
03701089514323 - VENTO Fixation Screw | 2024-02-19 |
03701089514330 - VENTO Fixation Screw | 2024-02-19 |
03701089514347 - VENTO Fixation Screw | 2024-02-19 |
03701089514354 - VENTO Fixation Screw | 2024-02-19 |
03701089514361 - VENTO Fixation Screw | 2024-02-19 |